Tatvacare - Quality Manager

Summary

• Establish, implement, and maintain ISO 9001-compliant Quality Management Systems.
• Develop and manage standard operating procedures (SOPs) across departments.
• Oversee internal and external quality audits.
• Ensure CAPA (Corrective and Preventive Action) processes are implemented effectively.
• Regulatory Compliance:
• Ensure compliance like HIPPA, GDPR and relevant HealthTech regulatory standards.
• Product & Software Quality Assurance:
• Oversee quality assurance for digital health software (SaMD) and connected medical devices.
• Conduct quality checks during software development lifecycle - including validation, verification, and usability testing.
• Continuous Improvement:
• Lead root-cause analysis and implement process improvements.
• Monitor KPIs and drive quality metrics across the organization.
• Promote a culture of continuous improvement through training and engagement.
• Key Skills and Competencies:
• Strong knowledge of ISO 13485, ISO 9001, and others.
• Experience in handling external audits.
• Excellent analytical and problem-solving skills.
• Strong communication and leadership skills for cross-functional collaboration.
• Experience with QMS software.
  

Desired Candidate Profile

• Bachelor's or master's degree in pharmacy, Life Sciences, Engineering, or related field.
• 5+ years of experience in Quality Assurance and/or Regulatory Affairs in the pharmaceutical, Health-tech industry. Strong understanding of ISO standards, and regulatory guidelines.
• Excellent communication, leadership, and organizational skills
• Knowledge of data privacy and cybersecurity standards (GDPR, HIPAA) is an advantage.